A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer

Sponsor

Hutchison Medipharma Limited (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02897479

Collaborator

(none)

Enrollment

Locations

Arm

60.9

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients and other NSCLC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.

Condition or Disease	Intervention/Treatment	Phase
Lung Sarcomatoid Carcinoma	Drug: Savolitinib	Phase 2

Detailed Description

Savolitinib will be administrated 600mg or 400mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Open-label Study to Evaluate the Efficacy and Safety of HMPL-504 in Locally Advanced/Metastatic MET-Mutation-Positive Pulmonary Sarcomatoid Carcinomas and Other Non-small Cell Lung Cancer

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Savolitinib Pulmonary Sarcomatoid Carcinomas	Drug: Savolitinib Enrolled patients will be treated with Savolitinib 600mg or 400mg once per day(QD), till disease progression, death or unacceptable toxicity, whichever comes first. A cycle of study treatment will be defined as 21 days of continuous dosing. Other Names: hmpl-504

Arm

Intervention/Treatment

Experimental: Savolitinib

Pulmonary Sarcomatoid Carcinomas

Drug: Savolitinib

Enrolled patients will be treated with Savolitinib 600mg or 400mg once per day(QD), till disease progression, death or unacceptable toxicity, whichever comes first. A cycle of study treatment will be defined as 21 days of continuous dosing.

Other Names:

hmpl-504

Outcome Measures

Primary Outcome Measures

To assess objective response rate (ORR) [1year]
ORR is defined as the proportion of patients with complete response or partial response. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks and in this study, it could be performed by the scheduled tumor assessment 6 weeks later

Secondary Outcome Measures

Progression free survival(PFS) [1year]
PFS is defined as the Progression free surviva of patients with complete response or partial response or stable disease. In the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
Safety Assessment Parameter [1year]
The safety will be assessed using the following safety outcome measures: incidence of adverse events, physical examinations,vital signs and laboratory tests (including hematology, clinical chemistry, urine tests and other indicators)12-ECG parameters and echocardiogram.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1.Fully understood the study and voluntarily signed Informed Consent Form
2.Age > 18 years
3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients and other Non-small cell lung cancer（NSCLC） with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy
4.Patient should have measurable disease per RECIST1.1
5.ECOG performance status of 0, or 1
6.Expected survival > 12 weeks

Exclusion Criteria:

1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ.
2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment
3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
4.Herbal therapy within 1 week prior to the initiation of study treatment
1. has EGFR, ALK or ROS 1 positive mutation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hopspital	Beijing	Beijing	China
2	Shanghai Chest Hospital	Shanghai	Shanghai	China	210000

Sponsors and Collaborators

Hutchison Medipharma Limited

Investigators

Principal Investigator: Shun LU, doctor, Shanghai Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hutchison Medipharma Limited

ClinicalTrials.gov Identifier:

NCT02897479

Other Study ID Numbers:

2016-504-00CH1

First Posted:

Sep 13, 2016

Last Update Posted:

Nov 30, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Carcinoma

Study Results

No Results Posted as of Nov 30, 2021